The U.S. Food and Drug Administration today approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant.

The U.S. Food and Drug Administration today approved Benlysta (belimumab) intravenous infusion for treatment of children with systemic lupus erythematosus – often referred to as simply "lupus" – a serious chronic disease that causes inflammation and damage to various body tissues and organs.

The U.S. Food and Drug Administration today granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose.

The U.S. Food and Drug Administration today ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately.

The U.S. Food and Drug Administration today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.

The U.S. Food and Drug Administration today issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi (flibanserin), that requires the company to revise important safety information that women and their health care professionals need to have when considering use of the drug.

Today, the U.S. Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI.

Today, as part of the Trump Administration's Winning on Reducing Food Waste Month, the U.S. Department of Agriculture, the U.S. Environmental Protection Agency, and the U.S. Food and Drug Administration announced the release of a federal interagency strategy to address food waste.

The U.S. Food and Drug Administration today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.

The U.S. Food and Drug Administration and the U.S. Customs and Border Protection leaders signed an agreement today to maximize inspection and detection capabilities in order to prevent illegal and harmful products entering the U.S. through the nation's International Mail Facilities and Ports of Entry that pose a threat to public health.

The U.S. Food and Drug Administration today posted warning letters to four companies who produce homeopathic drug products for significant violations of current good manufacturing practice regulations, including a letter to King Bio Inc. of Asheville, N.C.

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